MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; SCREW, FIXATION, BONE

Catalog Number 04.511.206.01C

Device Problem No Apparent Adverse Event (3189)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2019, the patient reported mild discomfort, swelling, and puss on the left side of the mandible and a "funny taste in the mouth".Upon inspection, there were small amounts of puss overlying on an anterior/distal segment part of the plate on the left side of the mandible.Originally, the patient had an open reduction internal fixation (orif) surgery for implantation of trumatch midface/mandible titanium (ti) plate, trumatch midface/mandible titanium (ti) guide, and thirty-nine (39) matrix screws on (b)(6) 2019.The patient was scheduled for a bi sagittal split osteotomy of the mandible and removal of the plate on (b)(6) 2019.It is unknown if the revision occurred.Patient status is unknown.This report is for one (1) 1.85mm ti matrix screw self-tapping/6mm.(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was noted the revision procedure occurred on (b)(6) 2019 as planned.The plates and screws were removed.There were no issues during the revision procedure and the patient outcome was reported as fine/stable.

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8803285
• MDR Text Key: 151459649
• Report Number: 8030965-2019-66364
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819358140
• UDI-Public: (01)07611819358140
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.206.01C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention